MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIO- COMPOSITE SUTURETAK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTURE ANCHOR, BIO- COMPOSITE SUTURETAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint is confirmed.Visual inspection identified that the implant 3mm bio-suturetak was broken at the base that is attached to the suture inside the shaft of the suture anchor, biocomposite suturetak ® 3 x 14.5 mm with #2 fiberwire.No damage was noted to the driver shaft blue suture.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to excessive impaction during anchor insertion and/or prying/leveraging during use.
Event or Problem Description
On 11/6/2023, it was reported by an arthrex subsidiary employee via email that an ar-1934bcf biocomposite suturetak anchor broke during insertion.All the broken fragments were retrieved, and the case was completed using another ar-1934bcf biocomposite suturetak.This was discovered during an rcr procedure on (b)(6) 2023.

• Brand Name: SUTURE ANCHOR, BIO- COMPOSITE SUTURETAK
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 21102966
• Report Number: 1220246-2025-09280
• Device Sequence Number: 20991885
• Product Code: MAI
• UDI-Device Identifier: 00888867023871
• UDI-Public: 00888867023871
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SUTURE ANCHOR, BIO- COMPOSITE SUTURETAK
• Device Catalogue Number: AR-1934BCF
• Device Lot Number: 15018713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown